
浏览全部资源
扫码关注微信
1.大连理工大学附属肿瘤医院(辽宁省肿瘤医院/辽宁省肿瘤 研究所)内镜科,沈阳;110042
2.锦州医科大学附属第一医院消化内科,辽宁 锦州 121001
3.大连理工大学附属肿瘤医院(辽宁省肿瘤医院/辽宁省肿瘤研究所)胃外科,沈阳 110042
主治医师,博士。研究方向:消化道肿瘤的内镜诊疗及综合治疗。E-mail:sunyijun0513@163.com
主治医师,硕士。研究方向:消化道肿瘤的综合治疗。E-mail:fly23411015@126.com
收稿:2026-03-04,
修回:2026-06-18,
录用:2026-06-19,
网络首发:2026-07-24,
纸质出版:2026-07-30
移动端阅览
祝平,李晓飞,朱佳,等.卡度尼利单抗联合化疗用于HER2中/低/不表达晚期胃腺癌或食管胃结合部腺癌的临床观察 [J].中国药房,2026,37(14):1868-1873.
ZHU Ping,LI Xiaofei,ZHU Jia,et al.Clinical observation of cadonilimab plus chemotherapy in advanced gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction with intermediate, low, or no HER2 expression[J].ZHONGGUO YAOFANG,2026,37(14):1868-1873.
祝平,李晓飞,朱佳,等.卡度尼利单抗联合化疗用于HER2中/低/不表达晚期胃腺癌或食管胃结合部腺癌的临床观察 [J].中国药房,2026,37(14):1868-1873. DOI: 10.6039/j.issn.1001-0408.2026.14.12.
ZHU Ping,LI Xiaofei,ZHU Jia,et al.Clinical observation of cadonilimab plus chemotherapy in advanced gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction with intermediate, low, or no HER2 expression[J].ZHONGGUO YAOFANG,2026,37(14):1868-1873. DOI: 10.6039/j.issn.1001-0408.2026.14.12.
目的
2
考察卡度尼利单抗联合化疗在人表皮生长因子受体2(HER2)中表达、低表达或不表达晚期胃腺癌或食管胃结合部腺癌(AEG)中的效果及安全性。
方法
2
回顾性选取2024年10月1日至2025年6月30日于辽宁省肿瘤医院就诊的HER2中表达、低表达或不表达晚期胃腺癌或AEG患者为研究对象,按照治疗方案分为A组[卡度尼利单抗联合奥沙利铂+卡培他滨(XELOX)方案,
n
=54
]
、B组(信迪利单抗联合XELOX方案,
n
=68)及C组(替雷利珠单抗联合XELOX方案,
n
=49)。比较3组患者治疗4个周期后的近期疗效、生存期及不良反应差异,并进一步采用Cox回归及Logistic回归分析治疗方案和基线资料对生存结局及3~4级治疗相关不良反应(TRAEs)的影响。
结果
2
3组患者的客观缓解率和疾病控制率比较,差异均无统计学意义(
P
>0.05)。A组患者的中位无进展生存期为7.56(5.62,8.11)个月,B组为7.23(5.33,8.23)个月,C组为7.33(5.42,8.19)个月,3组比较差异无统计学意义(
P
>0.05)。A组患者的中位总生存期(mOS)为11.67(8.82,13.88)个月,B组为9.78(6.82,12.73)个月,C组为9.69(6.78,12.66)个月,A组显著长于B组和C组(
P
<
0.05),而B组和C组的差异无统计学意义(
P
>0.05)。相关性分析结果显示,治疗方案、美国东部肿瘤协作组体能状态评分、转移器官数目及腹膜转移可能与患者总生存期(OS)相关;治疗方案与3~4级TRAEs发生风险之间未见显著相关性。3组患者的1~2级或3~4级TRAEs发生率比较,差异均无统计学意义(
P
>0.05)。
结论
2
与信迪利单抗或替雷利珠单抗联合XELOX方案相比,卡度尼利单抗联合XELOX方案治疗HER2中表达、低表达或不表达晚期胃腺癌或AEG可能具有更明显的OS获益,且安全性相近,但仍需更大样本研究进一步验证。
OBJECTIVE
2
To evaluate the efficacy and safety of cadonilimab plus chemotherapy in patients with advanced gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction (AEG) with intermediate, low, or no human epidermal growth factor receptor 2 (HER2) expression.
METHODS
2
Patients with advanced gastric adenocarcinoma or AEG with intermediate, low, or no HER2 expression who were treated at Liaoning Cancer Hospital between October 1, 2024 and June 30, 2025 were retrospectively included. According to the treatment regimen received, the patients were divided into group A [cadonilimab plus oxaliplatin and capecitabine (XELOX),
n
=54
]
, group B (sintilimab plus XELOX,
n
=68), and group C (tislelizumab plus XELOX,
n
=49). Short-term efficacy after
4 cycles of treatment, survival outcomes, and adverse events were compared among the three groups. Cox regression and Logistic regression analyses were further performed to evaluate the effects of the treatment regimen and baseline data on survival outcomes and the risk of grade 3-4 treatment related adverse events (TRAEs).
RESULTS
2
No statistically significant differences in objective response rate or disease control rate were observed among the three groups (
P
>0.05). The median progression-free survival was 7.56 (5.62, 8.11) months in group A, 7.23 (5.33, 8.23) months in group B, and 7.33 (5.42, 8.19) months in group C, with no statistically significant difference among the three groups (
P
>0.05). The median overall survival (mOS) was 11.67 (8.82, 13.88) months in group A, 9.78 (6.82, 12.73) months in group B, and 9.69 (6.78, 12.66) months in group C. The mOS was significantly longer in group A than in group B and group C (
P
<0.05), whereas no statistically significant difference was observed between group B and group C (
P
>0.05). The correlation analysis indicated that treatment regimen, Eastern Cooperative Oncology Group performance status (ECOG PS), number of metastatic organs, and peritoneal metastasis may be associated with overall survival (OS). No significant association was observed between treatment regimen and the risk of grade 3-4 TRAEs. The incidences of grade 1-2 or grade 3-4 TRAEs did not differ significantly among the three groups (
P
>0.05).
CONCLUSIONS
2
In patients with advanced gastric adenocarcinoma or AEG with intermediate, low, or no HER2 expression, cadonilimab plus XELOX may provide a more significant OS benefit with a safety profile comparable to that of sintilimab or tislelizumab plus XELOX. Further studies with larger sample sizes are required to validate these findings.
Chen Y , Jia K , Xie Y , et al . The current landscape of gastric cancer and gastroesophageal junction cancer diagnosis and treatment in China:a comprehensive nationwide cohort analysis [J ] . J Hematol Oncol , 2025 , 18 ( 1 ): 42 .
中华医学会外科学分会腹腔镜与内镜外科学组 , 中国抗癌协会胃癌专业委员会 , 中国抗癌协会腔镜与机器人外科分会 , 等 . 精准外科胃癌转化治疗专家共识: 2025版 [J ] . 中华消化外科杂志 , 2025 , 24 ( 3 ): 281 - 292 .
Pang T , Nie M M , Yin K . The correlation between the margin of resection and prognosis in esophagogastric junction adenocarcinoma [J ] . World J Surg Oncol , 2023 , 21 ( 1 ): 316 .
Zheng Y H , Zhao E H . Recent advances in multidisciplinary therapy for adenocarcinoma of the esophagus and esophagogastric junction [J ] . World J Gastroenterol , 2022 , 28 ( 31 ): 4299 - 4309 .
Randon G , Lonardi S , Fassan M , et al . Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy in patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer(ARMANI):a randomised,open-label,multicentre,phase 3 trial [J ] . Lancet Oncol , 2024 , 25 ( 12 ): 1539 - 1550 .
Pu W J , Li S S , Zhang J L , et al . The efficacy and safety of PD-1/PD-L1 inhibitors in combination with chemotherapy as a first-line treatment for unresectable,locally advanced,HER2-negative gastric or gastroesophageal junction cancer:a meta-analysis of randomized controlled trials [J ] . Front Immunol , 2025 , 16 : 1566939 .
Qin S K , Bai Y X , Li J , et al . First-line pembrolizumab plus chemotherapy for HER2-negative advanced gastric cancer:China subgroup analysis of the randomized phase 3 KEYNOTE-859 study [J ] . Adv Ther , 2025 , 42 ( 4 ): 1892 - 1906 .
Pang X H , Huang Z L , Zhong T T , et al . Cadonilimab,a tetravalent PD-1/CTLA-4 bispecific antibody with trans-binding and enhanced target binding avidity [J ] . mAbs , 2023 , 15 ( 1 ): 2180794 .
中国临床肿瘤学会指南工作委员会 . 中国临床肿瘤学会(CSCO)胃癌诊疗指南2025 [M ] . 北京 : 人民卫生出版社 , 2025 : 76 - 77,82 .
Shen L , Zhang Y Q , Li Z Y , et al . First-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma:a randomized,double-blind,phase 3 trial [J ] . Nat Med , 2025 , 31 ( 4 ): 1163 - 1170 .
Zhou Z F , Yang Y Q , Chen S F , et al . Cost-effectiveness analysis of first-line cadonilimab plus chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma [J ] . Front Immunol , 2025 , 16 : 1575627 .
Oken M M , Creech R H , Tormey D C , et al . Toxicity and response criteria of the eastern cooperative oncology group [J ] . Am J Clin Oncol , 1982 , 5 ( 6 ): 649 - 655 .
Yu H L Bai Y P , Xie X Y , et al . RECIST 1.1 versus mRECIST for assessment of tumour response to mole-cular targeted therapies and disease outcomes in patients with hepatocellular carcinoma:a systematic review and meta-analysis [J ] . BMJ Open , 2022 , 12 ( 6 ): e052294 .
Freites-Martinez A , Santana N , Arias-Santiago S , et al . Using the common terminology criteria for adverse events (CTCAE-version 5.0) to evaluate the severity of adverse events of anticancer therapies [J ] . Actas Dermo Sifiliográficas Engl Ed , 2021 , 112 ( 1 ): 90 - 92 .
Rha S Y , Oh D Y , Yañez P , et al . Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer(KEYNOTE-859):a multicentre,randomised,double-blind,phase 3 trial [J ] . Lancet Oncol , 2023 , 24 ( 11 ): 1181 - 1195 .
Janjigian Y Y , Shitara K , Moehler M , et al . First-line nivo-lumab plus chemotherapy versus chemotherapy alone for advanced gastric,gastro-oesophageal junction,and oesophageal adenocarcinoma(CheckMate 649):a randomised,open-label,phase 3 trial [J ] . Lancet , 2021 , 398 ( 10294 ): 27 - 40 .
Xu J M , Jiang H P , Pan Y Y , et al . Sintilimab plus chemotherapy for unresectable gastric or gastroesophageal junction cancer:the ORIENT-16 randomized clinical trial [J ] . JAMA , 2023 , 330 ( 21 ): 2064 - 2074 .
Qiu M Z , Oh D Y , Kato K , et al . Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma:RATIONALE-305 randomised,double blind,phase 3 trial [J ] . BMJ , 2024 , 385 : e078876 .
Zhang Z , Yu J , Zhang Z Q , et al . The safety of cado-nilimab:a systematic review and single-arm meta-analysis [J ] . Cancer Med , 2025 , 14 ( 17 ): e71210 .
Hossain M A . A comprehensive review of immune checkpoint inhibitors for cancer treatment [J ] . Int Immunopharmacol , 2024 , 143 : 113365 .
0
浏览量
1
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010802024621